PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

Last updated: December 12, 2022
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Tennis Elbow

Sprains

Tendon Injuries

Treatment

N/A

Clinical Study ID

NCT05648032
201903076DIPC
  • Ages 25-65
  • All Genders

Study Summary

PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.

Eligibility Criteria

Inclusion

Lateral epicondylitis Inclusion Criteria:

  • Tenderness at lateral epicondyle more than 3 months
  • Ultrasound-confirmed lateral epicondylopathy
  • Pain VAS ≥ 3/10 during wrist resistive extension
  • No treatment response to NSAID and physiotherapy

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation
  • Carpal tunnel syndrome (the same arm) in one year
  • Cervical radiculopathy
  • Taking NSAID in one week
  • Receiving PRP or steroid injection in one month
  • History of bacteremia, cellulitis or skin ulcer in three months
  • Rheumatoid arthritis
  • Malignancy
  • Poorly controlled diabetets mellitus (DM), liver and kidner diseases
  • Severe anemia (Hb<5)
  • Thrombocytopenia
  • History of tennis elbow surgery
  • History of elbow trauma Supraspinatus calcific tendinis Inclusion Criteria:
  • Hawkins-Kennedy test or empty can test, one of which is positive
  • Ultrasound-confirmed (calcification > 2mm)
  • Pain VAS ≥ 3/10 over right deltoid area more than 3 months
  • No treatment response to NSAID and physiotherapy Exclusion Criteria:
  • Pregnancy or lactation
  • Carpal tunnel syndrome (the same arm) in one year
  • Cervical radiculopathy
  • Taking NSAID in one week
  • Receiving PRP or steroid injection in one month
  • History of bacteremia, cellulitis or skin ulcer in three months
  • Rheumatoid arthritis
  • Malignancy
  • Poorly controlled DM, liver and kidner diseases
  • Severe anemia (Hb<5)
  • Thrombocytopenia
  • History of shoulder surgery
  • History of shoulder trauma

Study Design

Total Participants: 180
Study Start date:
October 06, 2022
Estimated Completion Date:
April 30, 2025

Study Description

Lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis are common tendinopathies of the upper limb and both have negative impacts on the patients' quality of life. The former affects function of wrist extension due to degeneration of common extensor tendons; the latter causes severe pain and limitation of shoulder range of motion due to calcific deposits within the supraspinatus tendon. Current common injection therapies are ultrasound-guided injection of steroid or platelet-rich plasma (PRP).

Previous studies have shown that steroid injection provides early but short-term pain reduction, while PRP injection causes post-injection pain by inducing inflammation but provides long-term pain relief and functional improvement. It may provide early pain reduction with long-term tissue regeneration if combining steroid and PRP. A recent study on tennis elbow showed that inclusion of steroid in the autologous whole blood and 20% dextrose injection can reduce pain during early treatment, without interfering with the therapeutic effects.

Furthermore, disadvantages of current PRP include difficulty in quantifying platelet numbers and growth factor activity, and in long-term preservation. In this study lyophilized platelet (PLT) can solve these problems, which can be dissolved in saline before injection.

This 3-arm randomized controlled trial will divide subjects into the PLT group (group A), steroid group (group B) or PLT+steroid group (group C). Therapeutic effects will be evaluated by pain visual analogue scale (VAS), grip dynamometer, and disabilities of the arm, shoulder, and hand (DASH) questionnaires during follow-ups at 2nd, 4th, 6th, 12th and 24th week after treatment, and ultrasound at 12th and 24th week . The hypothesis is that PLT+steroid injection will have earlier pain reduction than PLT injection and longer effects of pain reduction and functional improvement.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

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